UPDATE 3-US issues new warning on misuse of J&J pain patch

Fri Dec 21, 2007 4:41pm EST
 
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(Adds reaction, generic makers, FDA quote, details on overdose symptoms)

By Lisa Richwine

WASHINGTON, Dec 21 (Reuters) - U.S. health officials issued the second warning since 2005 on Friday about deaths from misuse of Johnson & Johnson's (JNJ.N: Quote, Profile, Research) Duragesic pain-killing patch or generic versions.

Despite a July 2005 warning, the Food and Drug Administration "has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it," the agency said.

The patch delivers a potent narcotic called fentanyl through the skin. The product was approved in 1990 for patients with persistent, moderate-to-severe pain and whose bodies are used to opioids. That means they have used another strong opioid pain medicine around the clock for a week or longer.

Duragesic and generic copies are most commonly used to treat cancer patients, the FDA said, but some doctors have been inappropriately prescribing the patch for occasional or mild pain, post-surgical pain, or for headaches.

The FDA also said some patients had replaced the patch more often than directed, applied more patches than prescribed or exposed them to heat such as from a heating pad or hot tub. All of those scenarios can lead to dangerously high fentanyl levels in the blood.

"While these products fill an important need, improper use and misuse can be life-threatening. Therefore, it is crucial that doctors prescribe these products appropriately and that patients use them correctly," said Dr. Bob Rappaport, director of anesthesia, analgesia and rheumatology products at the FDA.

FDA officials said they were working to tally exactly how many problems were related to patch misuse, but could not provide a number on Friday.  Continued...

 

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